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Head of Regulatory CMC Large Molecules Development
A career at our company is an ongoing journey of discovery: our
57,000 people are shaping how the world lives, works and plays
through next generation advancements in healthcare, life science
and electronics. For more than 350 years and across the world we
have passionately pursued our curiosity to find novel and vibrant
ways of enhancing the lives of others.
The Global Regulatory Affairs CMC Group lead is accountable for
strategic oversight of the assigned GRA-CMC group of experts,
through inspirational leadership and expertise. This role reports
directly to the Head of GRA-CMC and collaborates and partners with
other Merck functions and other pharmaceutical companies in the
context of Trade and Regulatory Associations.This role supports the
CMC Regulatory strategy and Health Authority interactions.
- Endorse the global CMC-part of the regulatory strategy (RSD)
for the products under his/her responsibility. This encompasses
risk assessment, strategic support and advice.
- Support Health Authority interactions on CMC issues and lead in
case of critical submissions
- Setting GRA-CMC objectives at a group level in alignment with
the relevant stakeholders
- Collaboration with stakeholders on a management level, e.g.,
GRA and technical function leadership teams as per scope of
accountability, supervisory committees of partners, regulatory
authority senior managers
- Endorse the CCP regulatory assessment, country specific CMC
regulatory requirements and the regulatory strategy and risks of
proposed regulatory submissions in the CMC area
Who you are:
degree in a Life Science or related discipline (minimum MSc or
equivalent degree), higher degree preferable (e.g. PhD in a
Experience in leading teams within a matrixed organization
Minimum of 12 years of pharmaceutical industry experience, with
at least 6 years of global CMC regulatory experience
Strong people management and leadership skills at a group level
with a focus on building consensus through negotiation and best
- Excellent written and spoken communication skills in English
(knowledge of other European languages is an asset such as
What we offer: With us, there are always opportunities to break
new ground. We empower you to fulfil your ambitions, and our
diverse businesses offer various career moves to seek new horizons.
We trust you with responsibility early on and support you to draw
your own career map that is responsive to your aspirations and
priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
Job Requisition ID: 218173
Career Level: E - Professional (10+ years)
Working time model: full-time
Careers during Covid-19
Thank you for visiting our careers website, we are always
looking for curious minds to join our teams. We understand how much
the world is being impacted by the Covid-19 crisis and we want to
assure you that your safety is very important to us. To ensure that
everyone's health is protected, instead of a standard face-to-face
interview, it is likely that you will be offered alternative
digital interview options.
The Company is an Equal Employment Opportunity employer. No
employee or applicant for employment will be discriminated against
on the basis of race, color, religion, age, sex, sexual
orientation, national origin, ancestry, disability, military or
veteran status, genetic information, gender identity, transgender
status, marital status, or any other classification protected by
applicable federal, state, or local law. This policy of Equal
Employment Opportunity applies to all policies and programs
relating to recruitment and hiring, promotion, compensation,
benefits, discipline, termination, and all other terms and
conditions of employment. Any applicant or employee who believes
they have been discriminated against by the Company or anyone
acting on behalf of the Company must report any concerns to their
Human Resources Business Partner, Legal, or Compliance immediately.
The Company will not retaliate against any individual because they
made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces,
including during the job application process. Applicants who may
require accommodation during the application process should speak
with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET
Monday through Friday.
Nearest Major Market: Boston
Job Segment: Pharmaceutical, Science